BIONECT HYDROGEL SPRAY

K973724 · Fidia Pharmaceutical Corp. · MGQ · Sep 22, 1998 · SU

Device Facts

• Record ID: K973724
• Device Name: BIONECT HYDROGEL SPRAY
• Applicant: Fidia Pharmaceutical Corp.
• Product Code: MGQ · SU
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BIONECT® Hydrogel Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.

Device Story

BIONECT® Hydrogel Spray is a clear, aqueous hydrogel dressing composed of sodium hyaluronate and purified water. Applied topically to wounds, it creates a moist, soothing environment to support natural healing. Used in clinical settings for management of various dermal ulcers, surgical wounds, and burns. The device functions as a passive dressing; it does not accelerate healing or act as a permanent skin substitute. Healthcare providers apply the spray to the wound site to maintain moisture balance and protect the wound bed.

Clinical Evidence

Clinical experience from two trials (one controlled) conducted in Europe involving approximately 45 patients with various ulcers and surgical wounds. Results indicated the device is safe for its intended use. Biocompatibility testing (cytotoxicity, dermal irritation, dermal sensitization) performed on the bulk solution per ISO-10993.

Technological Characteristics

Aqueous hydrogel dressing; composition: sodium hyaluronate (polysaccharide biopolymer) and purified water. Clear, colorless solution. Provides moist wound environment. Biocompatibility tested per ISO-10993. Non-interactive dressing.

Indications for Use

Indicated for dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis, arterial, diabetic), wounds (cuts, abrasions, donor sites, post-operative incisions), skin irritations, and first/second degree burns. Not for third degree burns.

Predicate Devices

• BIONECT® Hydrogel

Submission Summary (Full Text)

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K973724

SEP 2 2 1998

510(k) Premarket Notification K973724 BIONECT® Hydrogel Spray Amendment No. 3

# fidia Pharmaceutical Corporation

July 1, 1998

#### 10. 510(k) SUMMARY

#### 10.1 Summary Information

#### 10.1.1 Submitter's name and address

FIDIA Pharmaceutical Corporation 2000 K Street, NW, Suite 700 Washington, DC 20006

Contact person and telephone number:

Roberto Fiorentini, M.D., President Telephone: [phone] Telefax: [phone]

Date summary was prepared:

July 1, 1998

#### 10.1.2 Name of the Device

| Trade Name: | BIONECT® Hydrogel Spray |
|----------------------|-----------------------------------------------------|
| Common Name: | Hyaluronic acid sodium salt hydrogel dressing spray |
| Classification Name: | Hydrogel Wound and Burn Dressing |

#### 10.1.3 Identification of predicate device to which substantial equivalence is being claimed

BIONECT® Hydrogel Spray is substantially equivalent in function and intended use to the following cleared non-interactive wound and burn dressing: BIONECT® Hydrogel.

#### 10.1.4 Device description

Explanation of how the device functions: BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

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## fidia Pharmaceutical Corporation

July 1, 1998

Basic scientific concepts that form the basis for the device: BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: BIONECT® Hydrogel is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

### 10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

BIONECT® Hydrogel Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.

These indication statements are not substantially different from the predicate device identified in Section 10.1.3.

### 10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device

The technological characteristics of the device such as occlusion, bioburden level, and moist wound healing are not different from the predicate device cited.

#### Assessment of performance data 10.2

In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the bulk solution that impregnates BIONECT® Hydrogel Spray in accordance with FDA recommendations.6 These tests all support the safe use of BIONECT® Hydrogel Spray as a hydrogel temporary dressing in contact with breached or compromised skin.

⁶ Office of Device Evaluation General Program Memorandum #695-1, International Standard ISO-10993, "Biological Evaluation of Medical Devices part 1: Evaluation and Testing," dated 1 May 1995.

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510(k) Premarket Notification K973724 BIONECT® Hydrogel Spray Amendment No. 3

# fidia Pharmaceutical Corporation

July 1, 1998

Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds in 2 clinical trials (1 controlled), all conducted in Europe, indicates that BIONECT® Hydrogel Spray is safe for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Roberto Fiorentini, M.D. President Fidia Pharmaceutical Corporation 2000 K Street, N.W., Suite 700 Washington, D.C. 20006

Re: K973721, K973722, K973724 and K973725 Trade Name: Bionect Hydrogel Gauze Pads, Bionect Hydrogel Foam Bionect Hyrdogel Spray and Bionect Clear Hydrogel Regulatory Class: Unclassified Product Code: MGO Dated: July 1 and July 8, 1998 Received: July 1 and July 9, 1998

Dear Dr. Fiorentini:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. These devices may not be labeled for use on third degree burns.
- 2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. These devices may not be labeled as a treatment or a cure for any type of wound. . . - --- ---

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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#### Page 2 - Roberto Fiorentini, M.D.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR). Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus. permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures _________________

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# fidia Pharmaceutical Corporation

July 1, 1998

#### 2. INDICATIONS FOR USE

510(k) Number (if known): K973724

Device Name: Indications for Use: BIONECT® Hydrogel Spray ~

BIONECT® Hydrogel Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.

Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K973724

R 801.109)

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